Download EHC_PGD

Patient Group Direction For The Administration or Supply Of Oral Progestogen-Only
Emergency Contraception (PEOC) Levonelle®1500 By Registered Community
Pharmacists and Nurses Employed By Torbay Care Trust
Procedure for reporting adverse drug reactions (ADRs): unusual or life threatening reactions require immediate medical attention.
Document allergies and other ADRs clearly in notes and inform Doctor/Pharmacist/Nurse for further reporting and action if required.
1. Clinical Condition
Definition of
Emergency hormonal post-coital contraception in females with a history of unprotected sexual
condition/situation
intercourse/failed contraception
Criteria for
Nurses
inclusion

Females aged 13 years and above, presenting within 72 hours of unprotected sexual intercourse
or failed contraception whose need for emergency contraception is defined by the protocol.

A patient has received EHC but has vomited within 3 hours of the dose (providing the repeat
dose will be taken within 72 hours of unprotected sexual activity).
Community Pharmacists


Criteria for
exclusion
Females aged 13 years -24 years, presenting within 72 hours of unprotected sexual intercourse
or failed contraception whose need for emergency contraception is defined by the protocol.
A patient aged 13 years – 24 years who has received EHC from the named pharmacist but has
vomited within 3 hours of the dose (providing the repeat dose will be taken within 72 hours of
unprotected sexual activity).
Community Pharmacists only

Female 25 years of age and over
Nurses and Community Pharmacists
Female:

Under 13 years of age

Under 16 years of age who is not considered to be ‘Fraser competent’

Over 16 years of age but who is considered to be a vulnerable adult
Immediate referral of female to GP, Contraceptive Services or Out of Hours services for EHC.
Child protection issues must be addressed as per training.

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Caution
Presenting more than 72 hours after any unprotected sexual activity
With established or suspected pregnancy
Hypersensitive to any of the constituents of Levonelle® 1500
Taking ciclosporin – increased risk of toxicity of ciclosporin
Active acute porphyria
With severe liver disease
Any person identified as having other medical contraindications or currently (or within the last 4
weeks) taking a Liver Enzyme Inducing Drug – such as barbiturates (including primidone and
phenobarbital/phenobarbitone), carbamazepine (Tegretol®), phenytoin (Epanutin®),
oxcarbazepine, topiramate, rifampicin, rifabutin, , griseofulvin, Ritonavir and other drugs to treat
HIV – check individual drugs, herbal preparations containing Hypericum perforatum (St John’s
Wort), bosentan, oral tacrolimus, modafinil, proton pump inhibitors – check individual drugs.
Any situation where the pharmacist has reservations about supplying

Representatives of females requiring emergency hormonal contraception - supply to a 3rd
party is not permitted

Delivered a baby in last 3 weeks EHC is not required in these circumstances


In females aged 13-16 years consider child protection issues as per training
Anticoagulants – the anticoagulant effect of warfarin and phenindione is enhanced: the patient’s
GP should be informed to ensure follow up occurs and INR is checked 3 days later.
Taking the contraceptive pill (see protocol)
Breastfeeding – EHC not thought to be harmful but potential exposure can be reduced if the
woman takes the tablets immediately after feeding
Patient identified as having the following significant health problems: Severe hypertension,
diabetes mellitus and associated vascular or neuropathic complications, ischaemic heart
disease, stroke or a past history of breast cancer – obtain further specialist advice if unsure


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Suffering from severe malabsorption syndromes, such as Crohn’s Disease – obtain specialist
advice (see protocol)
TCT EHC PGD (Nurses/Pharmacists) Nov2007.doc 1 of 8
Action if excluded
Action if patient
refuses medication
Immediate referral to GP, Contraception Services or Out of Hours services for further assessment
and treatment.
Refer to GP, Contraception Services or Out of Hours services and advise to obtain a pregnancy test
2. Characteristics of Staff
Qualifications
The practitioner must hold one of the following registrations:
required

Registered Nurse

Registered Pharmacist accredited by Torbay Care Trust to supply EHC under a PGD.
Additional
requirements
Nurses (usually this will be a school nurse)
Attendance at foundation level child protection training as agreed with TCT named nurse and lead for
child protection (Cathy Hooper) through TCT child protection training programme.


Attendance at annual updates for child protection
TCT approval to operate under the TCT protocol for Emergency Contraception as PGD is to be
used in conjunction with this protocol
Working knowledge of:



TCT protocol for Emergency Contraception
TCT Medicines Policy
TCT Anaphylaxis Policy
Community Pharmacists


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Post registration
training
requirements
Working within a named accredited community pharmacy in Torbay Care Trust identified as an
area for supplying EHC under a PGD within the Local Enhanced Scheme.
The accredited Pharmacist must ensure their insurance policy includes professional indemnity
cover for undertaking this service.
TCT approval to operate under the TCT protocol for Emergency Contraception as PGD is to be
used in conjunction with this protocol
Nurses
Have successfully completed and been assessed as competent to supply EHC through one of the
following:

Emergency Contraception Training Programme provided by Contraceptive Services and
accredited by Torbay Care Trust and met competencies laid out within this programme. [Present
curriculum includes – the EHC PGD, contraception, ‘Fraser competency’, referrals and
communication skills]

Family Planning Training (to include EHC) within last 24 months.
Updating with relevant evidence of continued professional development. Maintenance of
competencies to operate under TCT protocol for Emergency Contraception and PGD for EHC
Community Pharmacists
Have successfully completed the:

CPPE training pack on Emergency Hormonal Contraception

Emergency Contraception Training Programme provided by Contraceptive Services and
accredited by Torbay Care Trust and met competencies laid out within this programme. [Present
curriculum includes –, the EHC PGD, clinical aspects of contraception, ‘Fraser competency’,
referrals and communication skills, child protection]
Updating with relevant evidence of continued professional development. Maintenance of
competencies to operate under the TCT protocol for Emergency Contraception and PGD for EHC
TCT EHC PGD (Nurses/Pharmacists) Nov2007.docPage 2 of 8
3.Description of Treatment
Name of Medicine
Levonorgestrel 1500 micrograms as Levonelle® 1500
Legal Class
POM (Prescription Only Medicine)
Storage
Dose to be used
(including criteria
for use of differing
doses)
Store below 25C

One tablet containing 1500micrograms levonorgestrel. It should be taken as soon as possible
and not later than 72 hours after unprotected sexual intercourse or failed contraception.
Method or route of
administration
Oral. The patient should be offered a glass of water and encouraged to take the dose at
presentation, but this is not mandatory.
Frequency of doses
Taken as a single dose, as soon as possible and not later than 72 hours after unprotected sexual
intercourse or failed contraception.
For women taking the contraceptive pill - see protocol
A maximum total of two separate doses may be taken in any one menstrual cycle. PLEASE NOTE
THIS IS AN UNLICENSED USE OF THIS DRUG.
Advice and
information to
patient/carer

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





Specify method of
recording supply
/administration
including audit trail
Discuss the efficacy of the emergency contraception
Advise on future contraception. Talk through patient information leaflet with patient and supply a
leaflet detailing local contraceptive services and the Family Planning Association ‘Emergency
Contraception’ and ‘Your Guide to Contraception’ leaflets. Advise a follow-up at the
Contraceptive Services Clinic or GP surgery.
Advise the patient that Levonelle® 1500 can sometimes cause nausea but that vomiting is very
unlikely to occur. However, if she does vomit within 3 hours of taking the medication to return to
the pharmacy or nurse or seek alternative medical advice as another dose will be required
immediately (providing the repeat dose is still within 72 hours of unprotected intercourse).
Explain to patient that she will not be protected from pregnancy for the rest of the cycle without
additional contraception (barrier methods).
Explain to the patient that she may experience disruption to the timing of her next period, but if
she is more than 7 days late she must have a pregnancy test.
Advise patient that she may have some intermenstrual bleeding before her next period.
Explain that the tablets are for emergency use only and not a regular method of contraception
because it is not effective as regular contraception.
Use of emergency contraception does not replace the necessary precautions against sexually
transmitted infections (STIs). Advise the patient on their exposure to STIs and give them details
of local GUM services.
Nurses and Community Pharmacists

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Ideally the patient should be encouraged to take the dose at presentation. However, should the
patient wish to take the medication away with her, the patient should be issued with a labelled,
original manufacturer’s pack containing one tablet and a patient information leaflet. The label
should contain the following - patient’s name, date of issue and directions for use, including time
of dose.
The practitioner should record the consultation by completing an assessment and record sheet,
including time and date of consultation. If levonorgestrel emergency contraception is supplied
then the practitioner and patient should sign only when the practitioner is confident that the client
understands the information she has been given.
For patients 18 years of age and over, the practitioner should retain the assessment and record
sheets for a period of 8 years. For patients under 18 years of age, the practitioner should retain
the assessment and record sheets until the patient is 25 years of age.
The patient should be asked if they wish their GP to be informed and supply may be
communicated if consent is given.
Community Pharmacists only



The pharmacist should complete the Enhanced Service claim form and submit to Torbay Care
Trust by the 5th day of the following month.
The pharmacist should complete the data monitoring form and submit to the Torbay Care Trust,
quarterly.
The pharmacist and Torbay Care Trust Assistant Director – Children’s Health,Torbay
Children Services will audit the service using the claim forms and record and assessment
sheets on an annual basis as part of ongoing continuing professional development.
Confidentiality
All practitioners and their supporting staff must respect their duty of confidentiality and information
should not be disclosed to any third party without the patient’s consent. This duty of confidentiality
applies equally to patients who are less than 16 years of age providing that child protection issues
have been addressed. Practitioners should be aware of their obligations under their appropriate
Code of Conduct/Ethics. The patient should be asked if they wish their GP to be informed and supply
may be communicated if consent is given.
Please refer to the Summary of Product Characteristics for full information.
This Patient Group Direction is operational from the beginning of February 2008 and expires January 2010.
TCT EHC PGD (Nurses/Pharmacists) Nov2007.docPage 3 of 8
Administration or Supply of Emergency Hormonal Contraception as Levonelle® 1500 by
Appropriately Registered and Qualified Practitioners Employed in Primary Care
This Patient Group Direction for use in Torbay Care Trust is Authorised by:
Job Title
Lead Doctor
Pharmaceutical Adviser
Lead Nurse
Name
Dr Catherine Ackford
Sam Smith
Jacquie Phare
Signed
Date
This Patient Group Direction is for use in _________________________ Community Pharmacy
and
is Authorised by:
To be used in conjunction with the PCT protocol for Emergency Contraception by Registered
Nurses and Named Community Pharmacists.
The practitioners named below, being Community Pharmacists based at
_______________________________________________ Pharmacy which has been accredited
under the Local Enhanced Scheme
or employees of Torbay Care Trust based at _________________________ are authorised to
administer Emergency Hormonal Contraception as Levonelle® 1500
as specified under this Patient Group Direction
I agree to supply the above preparation in accordance with this Patient Group Direction
Name of
Practitioner
Job Title
Signed
Authorising
Manager
Date
The protocols and PGDs for Emergency Hormonal Contraception ratified for use in Exeter NHS Walk In Centre and
East Devon PCT were used to prepare this document
Keep original with the authorising manager (line manager) and send a copy to Assistant Director –Children’s
Health, Torbay Children Services, Torbay Care Trust, Bay House, Riviera Park, Nicholson Road, Torquay, Devon,
TQ2 7TD.
This Patient Group Direction is operational from the beginning of February 2008 and expires January 2010.
TCT EHC PGD (Nurses/Pharmacists) Nov2007.docPage 4 of 8
Assessment and Record Sheet - Pharmacists
For females aged 13 years to 24 years
Name:
DOB:
GP:
Date:
Postcode (first part only):
Time consultation begins:
Day of the week: M T W Th F S Sun (PLEASE CIRCLE)
Did the risk take place within the previous 72 hours and has
the patient declined an IUD?
Time since unprotected sexual intercourse:
Contraceptive Services or GP
for consideration of PC IUD
NO
YES
LMP date if known………………………………………………
Explain to patient that you cannot give
EHC if she is already pregnant, and
refer to her GP.
Was this a normal period for you?
NO
Was it at the expected time?
Special considerations
YES
Is patient taking the contraceptive pill?
Does the patient have a baby less than 3 weeks old?
Time limits
YES
Refer to chart in protocol for guidelines
YES
EHC not needed, contraception should
be used from day 21.
YES
Contraceptive Services or GP
for consideration of PC IUD
YES
Levonelle® 1500 may be supplied up to
twice per cycle. If inappropriate refer to
contraceptive services or GP for
consideration of IUD.
NO
Any earlier unprotected sex since LMP?
NO
Levonelle 1500 given already on one or more occasions since
LMP?
Medical advice required
NO
Does the patient have: known allergy to any ingredient in the
tablet?
Active severe liver disease?
Any other significant condition/illness?
Refer to GP
YES
NO
Concurrent Medication
Is the patient taking a hepatic enzyme-inducing drug? For
example
Barbiturates
Topiramate Oxcarbazepine
Phenytoin
Primidone
Ritonavir and some other drugs used to treat HIV
St John’s Wort
Rifampicin Rifabutin
Modafinil
Oral tacrolimus
Carbamazepine
Bosentan
Griseofulvin
Some Proton Pump Inhibitors
Is the patient taking Ciclosporin?
YES
Refer to GP
YES
Refer to GP.
Is the patient taking anticoagulant medication (warfarin or
phenindione)
YES
Levonelle® 1500 may be given. Refer
to GP to ensure follow up occurs and
INR checked 3 days later
Is patient breastfeeding?
YES
Levonelle® 1500 may be given. Tablets
should be taken immediately after a
breastfeed. Also consider IUD.
TCT EHC PGD (Nurses/Pharmacists) Nov2007.docPage 5 of 8
Assessment and Record Sheet - Pharmacists
Females aged 13-16 years
Please
tick
Do you consider she is sufficiently mature and able to understand the
advice you have given?
Do you consider it in her best interests to have EHC?
Have you considered the possibility that she may have been abused or
raped?
Have you advised her to discuss the situation with her parents/guardian?
Have child protection issues been addressed?
All Females (aged 13 years to 24 years)
Counselling prompts
Verbal information given
How to take Levonelle® 1500
What to expect
Effectiveness
Advice re contraception, i.e. abstinence or condoms until next period
Has she understood that the consultation is confidential?
YES/NO
N.B. For females less than 16 years of age this will be providing
child protection issues have been addressed.
Does she wish GP to be informed?
YES/NO
Follow up arrangements, especially if no period
Advice on Sexually Transmitted Infections given
Contraceptive Services telephone number/leaflet given
ADDITIONAL INFORMATION (e.g. telephone discussions/advice from Dr/Contraceptive Services)
Patient outcome
Levonelle® 1500 given
YES
NO
Levonelle® 1500 supply
Batch Number:
Expiry Date:
Pharmacist’s Name
Signature
Patient’s Name
Signature
These forms will be held in a secure manner to maintain patient confidentiality (taking into account child protection
issues) and will only be used for record and audit purposes. For patients 18 years of age and over, the practitioner
should retain the assessment and record sheets for a period of 8 years. For patients under 18 years of age, the
practitioner should retain the assessment and record sheets until the patient is 25 years of age.
Assessment and Record Sheet - Nurses
For females aged 13 years and above
Name:
TCT EHC PGD (Nurses/Pharmacists) Nov2007.docPage 6 of 8
DOB:
GP:
Date:
Postcode (first part only):
Time consultation begins:
Day of the week: M T W Th F S Sun (PLEASE CIRCLE)
Did the risk take place within the previous 72 hours?
Refer to Contraceptive Services or GP
for consideration of PC IUD
Time since unprotected sexual intercourse:
NO
YES
LMP date if known………………………………………………
Explain to patient that you cannot give
EHC if she is already pregnant, and
refer to her GP.
Was this a normal period for you?
NO
Was it at the expected time?
Special considerations
YES
Is patient taking the contraceptive pill?
Does the patient have a baby less than 3 weeks old?
Time limits
YES
Refer to chart in protocol for guidelines
YES
EHC not needed, contraception should
be used from day 21.
YES
Refer to Contraceptive Services or GP
for consideration of PC IUD
YES
Levonelle® 1500 may be supplied up to
twice per cycle. If inappropriate refer to
contraceptive services or GP for
consideration of IUD.
NO
Any earlier unprotected sex since LMP?
NO
Levonelle® 1500 given already on one or more occasions
since LMP?
Medical advice required
NO
Does the patient have: known allergy to any ingredient in the
tablet?
Active severe liver disease?
Any other significant condition/illness?
Refer to GP
YES
NO
Concurrent Medication
Is the patient taking a hepatic enzyme-inducing drug? For
example
Barbiturates
Topiramate Oxcarbazepine
Phenytoin
Primidone
Ritonavir and some other drugs used to treat HIV
St John’s Wort
Rifampicin Rifabutin
Modafinil
Oral tacrolimus
Carbamazepine
Bosentan
Griseofulvin
Some Proton Pump Inhibitors
Is the patient taking Ciclosporin?
YES
Refer to GP
YES
Refer to GP.
Is the patient taking anticoagulant medication (warfarin or
phenindione)
YES
Levonelle® 1500 may be given. Refer
to GP to ensure follow up occurs and
INR checked 3 days later
Is patient breastfeeding?
YES
Levonelle® 1500 may be given. Tablets
should be taken immediately after a
breastfeed. Also consider IUD.
Assessment and Record Sheet - Nurses
Females aged 13-16 years
Please
tick
TCT EHC PGD (Nurses/Pharmacists) Nov2007.docPage 7 of 8
Do you consider she is sufficiently mature and able to understand the
advice you have given?
Do you consider it in her best interests to have EHC?
Have you considered the possibility that she may have been abused or
raped?
Have you advised her to discuss the situation with her parents/guardian?
Have child protection issues been addressed?
All Females (aged 13 years and above)
Counselling prompts
Verbal information given
How to take Levonelle 1500
What to expect
Effectiveness
Advice re contraception, i.e. abstinence or condoms until next period
Has she understood that the consultation is confidential?
YES/NO
N.B. For females less than 16 years of age this will be providing
child protection issues have been addressed.
Does she wish GP to be informed?
YES/NO
Follow up arrangements, especially if no period
Advice on Sexually Transmitted Infections given
Contraceptive Services telephone number/leaflet given
ADDITIONAL INFORMATION (e.g. telephone discussions/advice from Dr/Contraceptive Services)
Patient outcome
Levonelle 1500 given
YES
NO
Levonelle® 1500 supply
Batch Number:
Expiry Date:
Nurse’s Name
Signature
Patient’s Name
Signature
These forms will be held in a secure manner to maintain patient confidentiality (taking into account child protection
issues) and will only be used for record and audit purposes. For patients 18 years of age and over, the practitioner
should retain the assessment and record sheets for a period of 8 years. For patients under 18 years of age, the
practitioner should retain the assessment and record sheets until the patient is 25 years of age.
TCT EHC PGD (Nurses/Pharmacists) Nov2007.docPage 8 of 8